The first flow diverter, used to treat brain aneurysms in the United States was known as the Pipeline Embolization Device, which received its Federal Drug Administration approval based on the results of a prospective trial known as the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. This single-arm trial tested the use of this device on large and giant aneurysms that were considered otherwise untreatable or had failed prior attempts at conventional treatment. The initial results revealed that, in that over 70% of treated aneurysms were occluded at a six-month follow-up. This result, however, came with a risk of stroke or death in 5.6% of the patients, which was considered comparable to other treatments.

This paper highlights the long-term follow-up of the original patients from this trial, showing overall aneurysm occlusion rates of greater than 90% after five years with no additional major complications after the initial six-month follow-up. Importantly, treatment with flow diverters was durable, and there were no instances of an aneurysm recurring after successful occlusion.